CLASS II ONGOING Device recall · Reported 10 Apr 2024 · FDA Enforcement Report
Centurion hook kits labeled as: a) Sterile Skin Hook Fine recalled
MEDLINE INDUSTRIES, LP - Northfield is recalling Centurion hook kits labeled as: a) Sterile Skin Hook Fine (EA3975F), Product, distributed nationwide in the US. The recall was initiated on 23 Feb 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1435-2024
- FDA event ID
- 94136
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Feb 2024
- FDA classified
- 29 Mar 2024
- Reported
- 10 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 23 Feb 2024 | Recall initiated by company | |
| 29 Mar 2024 | Classified by FDA | +35 days |
| 10 Apr 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660; b) STERILE SMALL 2 PRONG SKIN HOOK (25754), Product Code 67105; c) STERILE NEWS TRACH HOOK(83300), Product Code 67810; d) STERILE LILLIE EAR HOOK DELICATE 7", Product Code I68655
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Questions about this recall
Is Centurion hook kits labeled as: a) Sterile Skin Hook Fine (EA3975F), Product recalled?
Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Centurion hook kits labeled as: a) Sterile Skin Hook Fine (EA3975F), Product on 23 Feb 2024. The recall is Class II and its status is Ongoing. Recall number Z-1435-2024.
Why was it recalled?
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Which lots are affected?
a) 66660, UDI/DI 60653160052154 (case) 00653160052152 (each), Lot Numbers: 2023042790, 2023091190; b) 67105, UDI/DI 60653160061880 (case) 00653160061888 (each), Lot Numbers: 2023042690; c) 67810, UDI/DI 30653160196703 (case) 00653160196702 (each), Lot Numbers: 2023060790, 2023070790; d) I68655, UDI/DI 00653160317220 (case) 10653160317227 (each), Lot Numbers: 2023061290
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from MEDLINE INDUSTRIES, LP - Northfield
All 792| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Medline medical convenience kits labeled as recalled | MEDLINE INDUSTRIES, LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline medical convenience kits labeled as recalled | MEDLINE INDUSTRIES, LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline ReNewal Reprocessed St. Jude Medical Response recalled | MEDLINE INDUSTRIES, LP - Northfield | Particulate Matter | Nationwide |
| Device | CLASS II | The Medline General Surgery Tray is customized to meet recalled | MEDLINE INDUSTRIES, LP - Northfield | Sterility | Nationwide |
| Device | CLASS II | Medline Kits containing BD SureStep Foley Tray Systems recalled | MEDLINE INDUSTRIES, LP - Northfield | Labeling Errors | FL, IL |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |